Neurovascular Coupling in Patients With Open Angle Glaucoma
Primary Purpose
Glaucoma
Status
Terminated
Phase
Locations
Austria
Study Type
Observational
Intervention
ocular blood flow measurements
Sponsored by
About this trial
This is an observational trial for Glaucoma focused on measuring glaucoma, ficker stimulation, ocular blood flow
Eligibility Criteria
Inclusion Criteria:
- Men and women aged between 20 and 80 years.
- Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
- Inclusion criteria of patients are open angle glaucoma.
- Men and women will be included in equal parts. A pregnancy test will be performed at screening.
- Ametropia of less than 3 diopters and anisometropia of less than 1 diopter.
Exclusion Criteria:
- Treatment with vasoactive drugs.
- Presence of intraocular pathology other than open angle glaucoma.
- Presence of ocular hypertension or PEX (pseudoexfoliation) glaucoma
- History or family history of epilepsy.
- Pregnancy.
- Diabetes mellitus.
Sites / Locations
- Department of Clinical Pharmacology, Meical University of Vienna, Austria
Arms of the Study
Arm 1
Arm 2
Arm Type
Arm Label
a
b
Arm Description
15 male and 15 female patients with glaucoma
30 sex matched healthy volunteers
Outcomes
Primary Outcome Measures
Retinal blood velocity (laser Doppler velocimetry)
Retinal arterial and venous diameter (Retinal vessel analyzer)
Optic nerve head blood flow (laser Doppler flowmetry)
Latency and amplitude (pattern ERG)
Secondary Outcome Measures
Mean arterial pressure
Full Information
NCT ID
NCT00811694
First Posted
July 2, 2008
Last Updated
November 20, 2014
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT00811694
Brief Title
Neurovascular Coupling in Patients With Open Angle Glaucoma
Official Title
Neurovascular Coupling in Patients With Open Angle Glaucoma
Study Type
Observational
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A variety of studies demonstrate that ocular blood flow is altered in glaucoma. Various animal and human studies have shown an increase in retinal and optic nerve head blood flow in response to diffuse luminance flicker. Based on studies with ERG, this effect has been attributed to augmented activity in the retinal ganglion cells and associated axons indicating a coupling mechanism between neuronal activity and retinal blood flow. Whereas a variety of studies have confirmed these effects, the knowledge about this coupling in the retina of patients with glaucoma is sparse.
Recently the investigators could show that flicker induced vasodilatation is blunted in patients with open angle glaucoma. However, the investigators results are limited by the fact that only data about retinal vessel diameters, not blood flow per se, are available. The further development of the investigators current flicker stimulation technique now allows us to determine blood flow velocity during flicker stimulation. Thus, in the current study, the investigators set out to determine whether this blood flow response is impaired in patients with glaucoma as compared to those in healthy volunteers and whether this is related to altered neural activity.
The study objective was, to investigate whether the blood flow response to flicker stimulation is altered in patients with glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, ficker stimulation, ocular blood flow
7. Study Design
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a
Arm Description
15 male and 15 female patients with glaucoma
Arm Title
b
Arm Description
30 sex matched healthy volunteers
Intervention Type
Other
Intervention Name(s)
ocular blood flow measurements
Intervention Description
non-invasive haemodynamic measurements of retinal vessel diameters, laser Doppler flowmetry and laser Doppler velocimetry
Primary Outcome Measure Information:
Title
Retinal blood velocity (laser Doppler velocimetry)
Time Frame
measurements done only once on the studyday
Title
Retinal arterial and venous diameter (Retinal vessel analyzer)
Time Frame
measurements done only once on the studyday
Title
Optic nerve head blood flow (laser Doppler flowmetry)
Time Frame
measurements done only once on the studyday
Title
Latency and amplitude (pattern ERG)
Time Frame
measurements done only once on the studyday
Secondary Outcome Measure Information:
Title
Mean arterial pressure
Time Frame
measurements done only once on the studyday
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women aged between 20 and 80 years.
Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
Inclusion criteria of patients are open angle glaucoma.
Men and women will be included in equal parts. A pregnancy test will be performed at screening.
Ametropia of less than 3 diopters and anisometropia of less than 1 diopter.
Exclusion Criteria:
Treatment with vasoactive drugs.
Presence of intraocular pathology other than open angle glaucoma.
Presence of ocular hypertension or PEX (pseudoexfoliation) glaucoma
History or family history of epilepsy.
Pregnancy.
Diabetes mellitus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriele Fuchsjäger Mayrl, MD
Organizational Affiliation
Department of Clinical Pharmacology, Meical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Pharmacology, Meical University of Vienna, Austria
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Neurovascular Coupling in Patients With Open Angle Glaucoma
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